Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)
I. To determine the effect of induction chemotherapy (IC) (intensive acute myeloid leukemia
[AML]-like therapy), versus less intensive hypomethylation agent (HMA) as initial therapy,
on failure-free survival.
I. Determine if IC (intensive AML-like therapy) in comparison to HMA as initial therapy,
will affect transplantation frequency, quality of life, pre-hematopoietic cell
transplantation (HCT) toxicity, and transplant candidacy.
II. Conduct exploratory analysis of post-HCT outcomes (overall survival, non relapse
mortality, incidence of graft rejection, graft-versus-host disease [GVHD], relapse, and
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC)
for 7 days. Treatment repeats every 28 days for 4 courses of decitabine or 6 courses of
azacitidine in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive cytarabine IV continuously over 24 hours for 7 days and idarubicin
IV or daunorubicin hydrochloride IV on days 1-3 at the discretion of the treating physician.
Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or
After completion of study treatment, patients are followed up for 18 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Failure-free survival (failure defined as death, lack of response to initial therapy, relapse after response to initial therapy)
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|